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This article by By Jerome Burne
"The complicated and confusing debate about statins – are they worth taking or not; are they safe or do they have nasty side effect? – has suddenly plunged into anarchic and uncharted territory by the claims of a new rival drug.
Senior figures in the cardiology establishment have long claimed statin side effects are few and usually mild. Researchers who claimed last year that as many as 20% of patients taking statins suffered side effects, were roundly attacked by Professor Sir Rory Collins of the prestigious Cholesterol Treatment Trialists’ Collaboration (CTT) in Oxford, for spreading alarm.
But this week a big trial of a new sort of cholesterol lowering drug has reported that nearly 50% of a group of patients taking a statin because their risk of heart disease was high had to stop because their muscle pains were so bad.
So where does this leave the poor patient hoping for cardiovascular protection or indeed official bodies like NICE which recently issued new evidence based guidelines recommending that an estimated 6 million more people should be taking statins because they were so safe?
The researchers vilified last year for putting the side effect risk at 20% have now been totally outflanked on the scale of the problem by a drug company. Drug companies are usually accused of hiding side-effects. What is going on?
Many people can’t tolerate statins
A clue can be found in the opening paragraph of the new study which blandly asserts there is a serious problems with statins which, and this is the important bit, the new drug being trialed is able to solve.
‘A significant proportion of patients with clinical indications for statin treatment,’ it reads ‘report an inability to tolerate evidence-based dose (of statins), most commonly because of muscle-related adverse effects.’
The stated aim of the trial was to uncover the scale of the problem. This is what it found. ‘Overall, 209 of 491 patients (42.6%) with a history of muscle-related adverse effects reported intolerable symptoms’ when given atorvastatin compared with a placebo.’
Time for a bit of background to make all his clear. The trial involved a new and fearsomely expensive drug called Repatha (Evolocumub) made by the drug company Amgen which will cost around £4,500 a year (for 12 monthly injections). Statins (now their patent has run out) cost £20 a year.
It is one of a new class of cholesterol lowering drugs known as PCSK9 inhibitors which bring down cholesterol even more efficiently than statins by blocking a protein in the liver called PCSK9 that’s why they are known as PCSK9 inhibitors.
The new problem with statins – intolerance
The purpose of this trial was to establish a market for this heavyweight cholesterol hammer. The first step was to establish that a significant number of statin patients were suffering from really bad muscle pains. As we’ve seen, they did this simply by asserting it.
The next step was not to talk so much about side –effects, something which the drug does to you – but about ‘intolerance’ – a problem that you have with the drug. And if you had this problem, its effect could be very dangerous. As the study says:
‘Patients with muscle-related intolerance often refuse to take statins despite elevated LDL-C levels and a high risk of major cardiovascular events.’
And this was where the new drug Repatha came in. Because it didn’t come with the same risk of unbearable muscle pains it could offer them a way out of this dangerous dilemma. So there is a clear incentive to find that the rate of statin induced muscle pain is sky high.
The fact that this flies in the face of decades papers finding in favour of the official statin line is simply ignored. And you don’t have to look for old research claiming statins tolerability. Here’s what an overview of statin safety says, which was published just over a month ago in the New English Journal of Medicine.
Rest of Jerome's article is here
http://healthinsightuk.org/2016/04/04/shock-twice-as-many-patients-suffer-muscle-pains-from-stains-as-experts-told-us-claims-new-rival-drug/
"The complicated and confusing debate about statins – are they worth taking or not; are they safe or do they have nasty side effect? – has suddenly plunged into anarchic and uncharted territory by the claims of a new rival drug.
Senior figures in the cardiology establishment have long claimed statin side effects are few and usually mild. Researchers who claimed last year that as many as 20% of patients taking statins suffered side effects, were roundly attacked by Professor Sir Rory Collins of the prestigious Cholesterol Treatment Trialists’ Collaboration (CTT) in Oxford, for spreading alarm.
But this week a big trial of a new sort of cholesterol lowering drug has reported that nearly 50% of a group of patients taking a statin because their risk of heart disease was high had to stop because their muscle pains were so bad.
So where does this leave the poor patient hoping for cardiovascular protection or indeed official bodies like NICE which recently issued new evidence based guidelines recommending that an estimated 6 million more people should be taking statins because they were so safe?
The researchers vilified last year for putting the side effect risk at 20% have now been totally outflanked on the scale of the problem by a drug company. Drug companies are usually accused of hiding side-effects. What is going on?
Many people can’t tolerate statins
A clue can be found in the opening paragraph of the new study which blandly asserts there is a serious problems with statins which, and this is the important bit, the new drug being trialed is able to solve.
‘A significant proportion of patients with clinical indications for statin treatment,’ it reads ‘report an inability to tolerate evidence-based dose (of statins), most commonly because of muscle-related adverse effects.’
The stated aim of the trial was to uncover the scale of the problem. This is what it found. ‘Overall, 209 of 491 patients (42.6%) with a history of muscle-related adverse effects reported intolerable symptoms’ when given atorvastatin compared with a placebo.’
Time for a bit of background to make all his clear. The trial involved a new and fearsomely expensive drug called Repatha (Evolocumub) made by the drug company Amgen which will cost around £4,500 a year (for 12 monthly injections). Statins (now their patent has run out) cost £20 a year.
It is one of a new class of cholesterol lowering drugs known as PCSK9 inhibitors which bring down cholesterol even more efficiently than statins by blocking a protein in the liver called PCSK9 that’s why they are known as PCSK9 inhibitors.
The new problem with statins – intolerance
The purpose of this trial was to establish a market for this heavyweight cholesterol hammer. The first step was to establish that a significant number of statin patients were suffering from really bad muscle pains. As we’ve seen, they did this simply by asserting it.
The next step was not to talk so much about side –effects, something which the drug does to you – but about ‘intolerance’ – a problem that you have with the drug. And if you had this problem, its effect could be very dangerous. As the study says:
‘Patients with muscle-related intolerance often refuse to take statins despite elevated LDL-C levels and a high risk of major cardiovascular events.’
And this was where the new drug Repatha came in. Because it didn’t come with the same risk of unbearable muscle pains it could offer them a way out of this dangerous dilemma. So there is a clear incentive to find that the rate of statin induced muscle pain is sky high.
The fact that this flies in the face of decades papers finding in favour of the official statin line is simply ignored. And you don’t have to look for old research claiming statins tolerability. Here’s what an overview of statin safety says, which was published just over a month ago in the New English Journal of Medicine.
Rest of Jerome's article is here
http://healthinsightuk.org/2016/04/04/shock-twice-as-many-patients-suffer-muscle-pains-from-stains-as-experts-told-us-claims-new-rival-drug/
